CFR section
21 CFR 820.184(d): Device history record
PART 820-QUALITY SYSTEM REGULATION · Subpart M-Records
Key facts
| Citation | 21 CFR 820.184(d) |
|---|---|
| Section | Device history record |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart M-Records |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR; |
At a glance
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- 10–99 Warning letters citing this section
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.